Pre-marketing phases of drug development (non-clinical and clinical trials) do not guarantee that all adverse drug reactions (ADRs) are discovered. Post-marketing safety surveillance is important for detection of any rare or delayed ADRs over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. A voluntary reporting system of ADRs is fundamental to drug safety monitoring; however, the under-reporting is its major limitation and it is not limited only to pharmacists.
Objectives: This study was designed to investigate attitudes and factors affecting voluntary reporting of adverse drug reactions by Croatian pharmacists.
Subjects and Methods: A 314 pharmacists voluntarily participated in this study. Data were collected by anonymous online questionnaire.
Results: It was found among responders that 41.72% (131) did not report any ADR in the period of one year, and that 71.88% (225) of responders do not report every ADR that encounter. Significantly more reporters of ADR were among the pharmacists who worked within the private pharmacy chains (p <0.01). The main factors that discouraged ADR reporting were uncertainty that drug caused ADR, ADR is well known for the drug, unavailability of patients' medical histories, lack of time or forgetfulness. When comparing results of this study with the investigation carried out among Croatian pharmacists from 2006 to 2009, the fear of revealing the identity of reporter and lack of knowledge are not listed among the most common constraints for non-reporting. Respondents show a positive attitude towards reporting ADR. 88.22% of respondents considered the reporting of ADRs to be integral part of professional role as a pharmacist. Simplified mode of reporting ADRs and further education were indicated by most responders as factors that would encourage ADR reporting.
Conclusion: The study’s findings contribute to an increased understanding of individual attitudes and factors that influence voluntary reporting of adverse drug reactions by Croatian pharmacists. Findings can be used for developing educational strategies focused on attitudes modification, as well as the development of tools to enhance reporting. Results suggest that there is a need for continuous education of pharmacists on the importance of ADR reporting.